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临床试验/NCT04186078
NCT04186078招募中不适用

Clinical Characteristics of Patients With Sleep Apnea in Korea: a Prospective Cohort Study

Seoul National University Hospital2 个研究点 分布在 2 个国家目标入组 1,000 人开始时间: 2019年11月11日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
1,000
试验地点
2
主要终点
The number of participants with adherence to positive airway pressure (PAP) therapy

研究概览

简要总结

Sleep-disordered breathing including obstructive sleep apnea (OSA) is an extremely common medical disorder associated with important morbidity. The purpose of this study is to understand the clinical features and course of patients with sleep apnea in Korea. Participants who are suspected of sleep apnea due to symptoms such as snoring, witnessed apneas, waking up with a choking sensation, excessive sleepiness, non-restorative sleep, difficulty initiating or maintaining sleep, fatigue or tiredness, and morning headache will be prospectively recruited at the outpatient clinic of Seoul National University Hospital. After polysomnography (PSG) or respiratory polygraphy, patients with sleep apnea including OSA and central sleep apnea (CSA) will be followed regularly. Participants not having sleep apnea (apnea-hypopnea index < 5/hour) will only have a baseline visit. For only participants with the informed consent of donating blood, their blood samples will be collected and stored in the Seoul National University Hospital-Human Biobank (SNUH-HUB).

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
19 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Participants who are suspected of sleep apnea due to symptoms such as snoring, witnessed apneas, waking up with a choking sensation, excessive sleepiness, non-restorative sleep, difficulty initiating or maintaining sleep, fatigue or tiredness, and morning headache

排除标准

  • 未提供

研究组 & 干预措施

control

apnea-hypopnea index < 5 per hour of sleep during a PSG or per hour of monitoring (respiratory polygraphy)

obstructive sleep apnea (OSA)

5 or more predominantly obstructive respiratory events [obstructive and mixed apneas, hypopneas or respiratory effort-related arousals (RERAs)] per hour of sleep during a PSG or per hour of monitoring (respiratory polygraphy)

central sleep apnea (CSA)

PSG shows all of the following:

  1. 5 or more central apneas and/or central hypopneas per hour of sleep.
  2. The number of central and/or central hypopneas is > 50% of the total number of apneas and hypopneas.

结局指标

主要结局

The number of participants with adherence to positive airway pressure (PAP) therapy

时间窗: Median follow up of 2 years

PAP adherence is defined as the use of PAP therapy for ≥4 h/night on ≥70% of nights

次要结局

  • The number of deaths(Median follow up of 15 years)
  • The cause of death(Median follow up of 15 years)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Jaeyoung Cho

Assistant Professor

Seoul National University Hospital

研究点 (2)

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